A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple-Ascending Dose Study to Characterize the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY4088044 in Healthy Participants.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 104
- 试验地点
- 8
- 主要终点
- Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
研究概览
简要总结
The purpose of this study is to evaluate how well LY4088044 is tolerated and what side effects may occur in healthy participants. The study drug will be administered either subcutaneously (SC) (under the skin) or intravenously (IV) (into a vein in the arm). Blood tests will be performed to check how much LY4088044 gets into the bloodstream and how long it takes the body to eliminate it.
The study will last up to approximately 92 weeks for Parts A, B, and C, excluding screening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
Sponsor is blinded
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and cardiac monitoring
- •Have a body mass index (BMI) within the range 18.5 to 30 kilogram per square meter (kg/m²)
排除标准
- •Are individuals assigned female at birth (AFAB) who are pregnant and/or lactating
- •Regularly use known drugs of abuse or show positive findings on urinary drug screening that are not consistent with their medication history
- •Participants with hemoglobin outside of the local laboratory normal range for age and gender, or evidence of iron deficiency, or hemoglobinopathy
- •Participants with estimated glomerular filtration rate (GFR) less than 90 milliliter per minute per 1.73 square meter (mL/min/1.73 m²)
- •Have a 12-lead electrocardiogram (ECG) abnormality
- •Smoke more than 10 cigarettes per day or the equivalent including electronic cigarettes AND are unable to abide by investigative site smoking restrictions
- •Have an average weekly alcohol intake that exceeds 21 units per week (males less than or equal to 65 years old) and 14 units per week (females and males over 65-year-old, if applicable) and are unwilling to abide by the restrictions
研究组 & 干预措施
LY4088044 (Part B)
SAD of LY4088044 administered subcutaneously (SC)
干预措施: LY4088044 (Drug)
Placebo (Part C)
Administered IV
干预措施: Placebo (Drug)
LY4088044 (Part A)
Single-ascending dose (SAD) of LY4088044 administered intravenously (IV)
干预措施: LY4088044 (Drug)
Placebo (Part A)
Administered IV
干预措施: Placebo (Drug)
Placebo (Part B)
Administered SC
干预措施: Placebo (Drug)
LY4088044 (Part C)
Multiple-ascending doses (MAD) of LY4088044 administered IV
干预措施: LY4088044 (Drug)
结局指标
主要结局
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
时间窗: Baseline up to Approximately Day 190
A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module
次要结局
- Pharmacodynamics (PD): Protein Levels in Skin Samples(Baseline up to Approximately Day 190)
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4088044(Baseline up to Approximately Day 190)
- PK: Area Under the Concentration Versus Time Curve (AUC) of LY4088044(Baseline up to Approximately Day 190)